CGM for Diabetes after Kidney Transplant

Overseen By Clinical Research Coordinators

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

Must be taking: Insulin

Must not be taking: Hydroxyurea

Disqualifiers: Type 1 diabetes, Visual impairment, Pregnancy, Cardiovascular disease, others

Trial Summary

What is the purpose of this trial?

This trial studies how a new technology can help people with diabetes who have had a kidney transplant manage their blood sugar levels more effectively. The technology provides constant data on blood sugar, allowing for better management.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking hydroxyurea.

What data supports the effectiveness of the treatment Dexcom G6 Continuous Glucose Monitoring System for diabetes management after kidney transplant?

The Dexcom G6 Continuous Glucose Monitoring System has shown consistent and acceptable accuracy in various settings, such as during elective abdominal surgery and in pediatric patients with Type 1 Diabetes, indicating its potential usefulness in managing blood sugar levels. Additionally, a modified algorithm for the Dexcom G6 improved data availability, which may enhance patient experience and integration into insulin delivery systems. ^{1 2 3 4 5}

Is the Dexcom G6 CGM System safe for use in humans?

The Dexcom G6 CGM System has been evaluated in various studies and shown to be generally safe for use in humans. In a study during elective abdominal surgery, no clinically significant adverse events were reported, and the device showed consistent accuracy. Additionally, an analysis of FDA adverse events indicated that while there were some complaints about inaccuracy, no major safety concerns were highlighted. ^{1 2 5 6 7}

How is the Dexcom G6 treatment unique for managing diabetes after a kidney transplant?

The Dexcom G6 is a continuous glucose monitoring (CGM) system that provides real-time glucose readings without the need for frequent finger pricks, making it easier to manage blood sugar levels after a kidney transplant. It offers consistent accuracy and increased data availability, which can improve glucose management and patient experience compared to traditional methods. ^{1 2 3 5 8}

Research Team

Ling Chen, MD

Principal Investigator

UCDavis Transplant Nephrology

Eligibility Criteria

This trial is for adults over 18 with Type 2 Diabetes who use insulin and have had a kidney transplant within the last year. Participants need functioning kidneys, access to home Wi-Fi, and must be able to test their blood sugar four times daily if using the blinded CGM. It's not for those with Type 1 Diabetes, unstable heart disease, active cancer treatment, significant visual or cognitive issues, or women who are pregnant/breastfeeding.

Inclusion Criteria

I am 18 years old or older.

Access to home wi-fi connection

I have Type 2 Diabetes and am taking insulin.

Exclusion Criteria

I have heart problems that are not well-controlled.

Prisoners

You are not able to wear the Dexcom G6 device all the time for any reason.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will either use continuous glucose monitoring (CGM) or self-monitoring of blood glucose (SMBG) for glycemic control

10 weeks

Regular monitoring with CGM or SMBG

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dexcom G6 (Continuous Glucose Monitoring)
• Dexcom G6 blinded sensor (Continuous Glucose Monitoring)

Trial Overview The study examines how continuous glucose monitoring (CGM) affects blood sugar control in diabetic kidney transplant patients. The Dexcom G6 device will be used to monitor glucose levels continuously to see if it helps maintain them within a target range.

Participant Groups

Group I: Continuous glucose monitoring (CGM) Active Control 1 Intervention

Those in the intervention arm will wear a continuous glucose monitoring device. They only need to perform blood glucose fingersticks if the CGM transmission is lost for a prolonged period of time or in cases of hypo- or hyperglycemia when symptoms don't align with blood glucose readings.

Group II: Self monitoring of blood glucose (fingersticks) Placebo Group 1 Intervention

The control arm will remain on standard-of-care SMBG while the intervention arm will use their CGM. The control arm utilizing SMBG will be required to have at minimum 4 glucose checks per day.

Dexcom G6 is already approved in Canada for the following indications:

Approved in Canada as Dexcom G6 for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control in diabetic patients

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Dahlia M Zuidema

Lead Sponsor

Trials

1

Recruited

80+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Findings from Research

The Abbott Freestyle Libre 1 glucose monitoring system demonstrated superior accuracy in adults undergoing hemodialysis, with a mean absolute relative difference (MARD) of 11.3% compared to 22.7% for the Dexcom G6, based on a study of 40 participants.

The Freestyle Libre 1 also showed a high percentage of readings within acceptable accuracy ranges, with 73.5% of readings within 15 mg/dL of reference values, indicating it is a reliable tool for glucose monitoring in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Accuracy of Continuous Glucose Sensors in People with Diabetes Undergoing Hemodialysis (ALPHA Study). Avari, P., Tang, W., Jugnee, N., et al.[2023]

The enhanced algorithm for the Dexcom G6 Continuous Glucose Monitoring (CGM) System maintained high accuracy, with a 91.8% accuracy rate, while significantly reducing sensor errors.

The new algorithm led to a 59% decrease in total time spent in sensor error, improving data availability, which could enhance patient experience and integration with insulin delivery systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. Harvey Towers, RA., Zhang, X., Yousefi, R., et al.[2022]

Flash glucose monitoring (FGM) is highly accurate and convenient for post-kidney transplant patients, showing a strong correlation (0.95) with traditional capillary blood glucose monitoring, while being quicker and less expensive.

Both patients and nursing staff preferred FGM over traditional methods, reporting high satisfaction with its usability, and it took significantly less time to perform (3.6 seconds for FGM vs. 64 seconds for CBGM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and nursing experience of flash glucose monitoring following kidney transplantation. Shaban, AA., Minas, K., Sunderland, A., et al.[2023]

The Dexcom G6 continuous glucose monitoring (CGM) system demonstrated a mean absolute relative difference (MARD) of 7.7% in accuracy when compared to laboratory blood glucose measurements, indicating high reliability for monitoring glucose levels in children and adolescents with type 1 diabetes.

With 96.2% of estimated glucose values falling within 20% of the reference values, the G6 system's accuracy supports its potential to enhance glycemic control and encourage consistent use among young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. Welsh, JB., Zhang, X., Puhr, SA., et al.[2020]

The Dexcom G6 continuous glucose monitoring system demonstrated acceptable accuracy during elective abdominal surgery, with a mean absolute relative difference of 12.7% between sensor readings and reference glucose values, based on 1207 data pairs from 20 adults.

No clinically significant adverse events were reported, indicating that the Dexcom G6 is a safe option for peri-operative glucose management in patients with (pre)diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a factory-calibrated, real-time continuous glucose monitoring system during elective abdominal surgery. Tripyla, A., Herzig, D., Joachim, D., et al.[2021]

The analysis of adverse events for the Medtronic 670G insulin pump revealed that users experienced more hypoglycemic events when the auto mode was activated compared to when it was turned off.

For the Dexcom continuous glucose monitors, complaints about inaccuracies were most common when the readings fell within the acceptable range (B zone), indicating potential confusion among users regarding the reliability of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. Krouwer, JS.[2022]

In a study of 25 pediatric patients who underwent total pancreatectomy with islet autotransplantation, the Dexcom G6 continuous glucose monitor (CGM) demonstrated clinically acceptable accuracy for glucose monitoring in the immediate postoperative period, with 100% of values deemed clinically acceptable.

The Dexcom G6 showed a mean absolute difference (MAD) of 14.7 mg/dL and a mean absolute relative difference (MARD) of 13.4%, indicating it can be a reliable tool for managing hyperglycemia, which is crucial for islet cell survival after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring in the Intensive Care Unit Following Total Pancreatectomy with Islet Autotransplantation in Children: Establishing Accuracy of the Dexcom G6 Model. Segev, N., Hornung, LN., Tellez, SE., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Accuracy of Continuous Glucose Sensors in People with Diabetes Undergoing Hemodialysis (ALPHA Study). [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Patient and nursing experience of flash glucose monitoring following kidney transplantation. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Performance of a factory-calibrated, real-time continuous glucose monitoring system during elective abdominal surgery. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring in the Intensive Care Unit Following Total Pancreatectomy with Islet Autotransplantation in Children: Establishing Accuracy of the Dexcom G6 Model. [2022]